NCT02193321

Brief Summary

The purpose of this study is to to evaluate the rate of new onset postoperative atrial fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial surface as compared to subjects who did not undergo epicardium intervention.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

July 15, 2014

Last Update Submit

November 30, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationAmniotic Membrane

Outcome Measures

Primary Outcomes (1)

  • Rate of new onset postoperative atrial fibrillation

    up to 7 days

Secondary Outcomes (1)

  • Procedure-related serious adverse events

    up to 30 days

Study Arms (2)

Amniotic membrane patch placement

EXPERIMENTAL

One amniotic membrane patch will be placed on the epicardial surface of the heart immediately following a CABG procedure prior to wound closure.

Biological: Amniotic Membrane Patch

Control

NO INTERVENTION

Amniotic membrane patch will not be placed after CABG procedure prior to wound closure.

Interventions

Amniotic Membrane PatchBIOLOGICAL
Also known as: PalinGen KardiaMembrane, PalinGen Kardia XPlus Membrane
Amniotic membrane patch placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • This cardiac operation is the subject's first or primary cardiac operation
  • The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
  • Must have ability to provide written informed consent
  • Must have ability to fulfill all of the expected requirements of this clinical protocol

You may not qualify if:

  • Prior history of atrial fibrillation
  • Prior history of open heart surgery
  • Prior history of pericarditis
  • Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone, or sotalol) in the past six months
  • The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
  • Concomitant procedure planned
  • In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively
  • Unexpected procedure (i.e., valve repair/replacement) or intraoperative findings creating an unreasonable intraoperative risk or an increased probability of postoperative complications in terms of recovery.
  • CABG procedure with \> 3 hours total on (cardiopulmonary bypass) CPB.
  • Prophylactic use of amiodarone.
  • Prophylactic use of amiodarone
  • No prophylactic, temporary pacing except for symptomatic bradycardia or advanced heart black as defined as:
  • Sinus bradycardia \< 40 beats per minute
  • Type 1 atrioventricular (AV) block
  • Type 2 AV block
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (12)

  • Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.

    PMID: 15082699BACKGROUND

  • Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.

    PMID: 11747385BACKGROUND

  • Burgess DC, Kilborn MJ, Keech AC. Interventions for prevention of post-operative atrial fibrillation and its complications after cardiac surgery: a meta-analysis. Eur Heart J. 2006 Dec;27(23):2846-57. doi: 10.1093/eurheartj/ehl272. Epub 2006 Oct 2.

    PMID: 17015402BACKGROUND

  • Maddox TM, Nash IS, Fuster V. Economic costs associated with atrial fibrillation. In: Natale A, Jalife J, ed 1. Atrial Fibrillation: from bench to bedside. Humana press: 13-26, 2008.

    BACKGROUND

  • Hamilton DR, Dani RS, Semlacher RA, Smith ER, Kieser TM, Tyberg JV. Right atrial and right ventricular transmural pressures in dogs and humans. Effects of the pericardium. Circulation. 1994 Nov;90(5):2492-500. doi: 10.1161/01.cir.90.5.2492.

    PMID: 7955207BACKGROUND

  • Crystal E, Connolly SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of postoperative atrial fibrillation in patients undergoing heart surgery: a meta-analysis. Circulation. 2002 Jul 2;106(1):75-80. doi: 10.1161/01.cir.0000021113.44111.3e.

    PMID: 12093773BACKGROUND

  • Guo Y, Lip GY, Apostolakis S. Inflammation in atrial fibrillation. J Am Coll Cardiol. 2012 Dec 4;60(22):2263-70. doi: 10.1016/j.jacc.2012.04.063.

    PMID: 23194937BACKGROUND

  • Cargnoni A, Di Marcello M, Campagnol M, Nassuato C, Albertini A, Parolini O. Amniotic membrane patching promotes ischemic rat heart repair. Cell Transplant. 2009;18(10):1147-59. doi: 10.3727/096368909X12483162196764. Epub 2009 Jun 22.

    PMID: 19650976BACKGROUND

  • Kim HG, Choi OH. Neovascularization in a mouse model via stem cells derived from human fetal amniotic membranes. Heart Vessels. 2011 Mar;26(2):196-205. doi: 10.1007/s00380-010-0064-6. Epub 2010 Dec 25.

    PMID: 21188388BACKGROUND

  • Toda A, Okabe M, Yoshida T, Nikaido T. The potential of amniotic membrane/amnion-derived cells for regeneration of various tissues. J Pharmacol Sci. 2007 Nov;105(3):215-28. doi: 10.1254/jphs.cr0070034. Epub 2007 Nov 6.

    PMID: 17986813BACKGROUND

  • Dobaczewski M, Gonzalez-Quesada C, Frangogiannis NG. The extracellular matrix as a modulator of the inflammatory and reparative response following myocardial infarction. J Mol Cell Cardiol. 2010 Mar;48(3):504-11. doi: 10.1016/j.yjmcc.2009.07.015. Epub 2009 Jul 23.

    PMID: 19631653BACKGROUND

  • Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.

    PMID: 25876055BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zain I Khalpey, MD,PhD,MRCS

    University of Arizona

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)